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Randomized Controlled Trial
. 2011 Nov 8;105(10):1495-502.
doi: 10.1038/bjc.2011.409. Epub 2011 Oct 11.

Health-related quality of life in patients with metastatic colorectal cancer treated with panitumumab in first- or second-line treatment

Affiliations
Randomized Controlled Trial

Health-related quality of life in patients with metastatic colorectal cancer treated with panitumumab in first- or second-line treatment

L Bennett et al. Br J Cancer. .

Abstract

Background: Panitumumab in combination with chemotherapy was evaluated in two pivotal clinical trials in first- and second-line treatment of metastatic colorectal cancer (mCRC), respectively. This analysis compared the health-related quality of life (HRQoL) of patients with or without panitumumab in the two trials.

Methods: Patients with mCRC were randomised to FOLFOX (first-line trial) or FOLFIRI (second-line trial)±panitumumab. The EuroQoL 5-Dimensions Health State Index (EQ-5D HSI) and Visual Analogue Scale (EQ-5D VAS) were assessed at baseline and monthly follow-up until disease progression. Patients with wild-type KRAS mCRC with baseline and post-baseline HRQoL scores were included. Difference in change from baseline between treatment groups was evaluated using linear mixed and pattern-mixture models.

Results: In the first-line trial, 576 patients with wild-type KRAS mCRC (284 panitumumab+FOLFOX4 and 292 FOLFOX4 alone) were included in the HRQoL analyses. In the second-line trial, 530 patients with wild-type KRAS mCRC were included in these analyses (263 panitumumab+FOLFIRI and 267 FOLFIRI alone). There was no significant difference in the change in EQ-5D HSI and VAS scores between treatment groups in either trial.

Conclusion: The addition of panitumumab to FOLFOX4 or FOLFIRI in first- or second-line treatment of wild-type KRAS mCRC significantly improved progression-free survival without compromising HRQoL.

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Conflict of interest statement

Lee Bennett, Xiaolei Zhou and Jessica Zhang are employees of RTI Health Solutions, and received funding from Amgen Inc. to perform the analyses reported in this paper. Zhongyun Zhao, Beth Barber, Feng Xu and Jeffrey Wiezorek are employees and stockholders of Amgen Inc. Marc Peeters acted as an investigator in the second-line trial discussed in this paper and has served as a speaker, a consultant and an advisory board member for Amgen, Lilly, Merck, Novartis, Roche and Sanofi-Aventis, and has received honoraria and research funding from Amgen. Jean-Yves Douillard acted as an Investigator in the first-line trial discussed in this paper and has served as a compensated consultant and an advisory board member for Amgen, Sanofi-Aventis, Merck Serono and Roche.

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